Cerebral Palsy
Conditions
Keywords
child
Brief summary
This study is considered a pilot exploratory study. Intervention, prospective, double-armed, randomized, placebo-control clinical trial. The therapeutic effect of oral Magnesium sulfate on spasticity and constipation will be studied.
Detailed description
Spasticity and constipation are major problems hindering improvement in motor development in children with cerebral palsy. Decreasing spasticity will have a positive effect on motor development and quality of life for the child and his family. The aim is to study the therapeutic and adverse effects of oral magnesium sulfate therapy on spasticity and constipation in infants and children with cerebral palsy. Hundred children with spastic cerebral palsy will be randomized to either intervention group n=50 will be treated with magnesium sulfate 4% orally for 28 days to treat spasticity and constipation in addition to their conventional treatment, or placebo group n=50 will receive conventional treatment and placebo.
Interventions
DIETARY_SUPPLEMENTOral magnesium sulfate
Magnesium sulfate 4% concentration in a dose of 65 mg/day for infants and children aged 1-3 years , 110 mg/day for those 3-8 years and 350 mg/day for those above 9 years .Each 1 ml of the magnesium sulfate used contains 0.325 mEq (milliequivalent) of elemental magnesium which equals to 4 mg elemental magnesium .
OTHERPlacebo
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Years
Healthy volunteers
No
Inclusion criteria
* Age below12 years. * Presence of spasticity without joint contracture Spasticity is defined as velocity dependent, increased resistance to passive muscle stretch. * Acceptance of caregivers to participate in the study and signing the written consent. * Constipation will be defined according to Rome lll criteria.presence of at least 2 of the following 2 motions week, history of painful or hard bowel movement, presence of large diameter stools that stools that may obstruct the toilets (Burgers et al., 2012).
Exclusion criteria
* Severe growth retardation (Below the 10th centile for weight and length charts children with cerebral palsy). * Gastrostomy tube feeding. * Joint contractures. * Congenital malformations. * Suspected inborn error of metabolism. * Suspected inherited neurologic disease. * Care giver's refusal to participate in the study. * Occurrence of side effects of oral magnesium sulfate. * Patients with cardiac, renal, GIT problem or chronic diarrhea.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in muscle tone evaluated by Modified Ashworth Index and constipation ROM-lll criteria | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in H/M ratio in H-reflex by electrophysiologic assessment | 1 month |
Countries
Egypt
Outcome results
None listed